Principal Scientist - Clinical Pharmacology, Modeling & Simulation

Role Summary

The Principal Scientist is a Subject Matter Expert in Clinical Pharmacology and Modeling & Simulation who will drive innovative modeling and simulation strategies for translational approaches to support clinical dosage selections and clinical study designs. The role spans therapeutic areas such as oncology, rare diseases, obesity, and cardiovascular disease, and modalities from small molecules and mAbs to novel modalities. You will apply quantitative translational and clinical pharmacology approaches integrated with emerging machine learning and generative AI to guide optimal clinical drug development.

Responsibilities

• Drive innovative modeling and simulation strategies for translational approaches to support clinical dosage selections and clinical study designs across multiple therapeutic areas and modalities.
• Apply PK/PD modeling, mechanistic PBPK/PD modeling, and QSP modeling to inform clinical study designs, dosage selection, drug–drug interactions, special populations, ethnic sensitivity, pediatric and biopharmaceutics studies, and to integrate results into regulatory filings and product labels.

Qualifications

• Required:
  • Doctorate degree and 2 years of Clinical Pharmacology and Modeling & Simulation experience
  • Or Master’s degree and 4 years of Clinical Pharmacology and Modeling & Simulation experience
  • Or Bachelor’s degree and 6 years of Clinical Pharmacology and Modeling & Simulation experience
  • Or Associate’s degree and 10 years of Clinical Pharmacology and Modeling & Simulation experience
  • Or High school diploma / GED and 12 years of Clinical Pharmacology and Modeling & Simulation experience
• Preferred:
  • PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology or Chemical Engineering or equivalent; e.g., MD, PharmD)
  • 5+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry
  • Hands-on experience in PK/PD, M-PBPK, M-PBPK-PD, and QSP modeling to inform clinical study designs and dosage selection; expert knowledge of PK/PD, M-PBPK, M-PBPK-PD, and QSP software
  • Established track record of Model Based Drug Development (MIDD)
  • Experience interacting with global health authorities and authoring regulatory documents; knowledge of global regulatory requirements
  • Experience leading clinical pharmacology and biopharmaceutics studies (bioequivalence, bio-comparability, DDI, special populations, ADME, pediatric) and integrating results into regulatory filings and labels

Skills

• Quantitative Clinical Pharmacology approaches with a focus on PK/PD, M-PBPK, M-PBPK-PD, and QSP modeling
• Integration of emerging Machine Learning and Generative AI approaches into drug development workflows
• Strong collaboration and regulatory interactions; ability to contribute to regulatory documents and guidance